a study of ba1202 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a multicenter, open-label, single-arm phase i study in patients with advanced solid tumors which consists of a dose escalation part (part a) and a dose extension part (part b). part a aims to evaluate the safety and tolerability of ba1202, and determine the mtd. part b will also evaluate the preliminary efficacy of ba1202.


Eligibility criteria:
inclusion criteria: * patients who voluntarily sign an irb-approved informed consent form, and are willing to abide by the restrictions of the study. * part a: patients with histologically and/or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on standard-of-care (soc), are intolerant to soc, or have no soc. * part b: patients with histologically and/or cytologically confirmed colorectal cancer, non-small cell lung cancer, pancreatic cancer, gastric cancer, who have progressed on standard-of-care (soc), are intolerant to soc, or have no soc.（specific cohort will be determined after data of dose escalation phase is obtained） * part b: high expression of ceacam5 (defined as ≥ 20% of tumor cells with ihc 2+ and/or 3+). * life expectancy of at least 3 months. * at least one evaluable lesion in part a and at least one measurable lesion in part b according to recist v1.1. * ecog score of \< 2. * absolute neutrophil count ≥ 1.5 x 10\^9/l, platelet count ≥ 100 x 10\^9/l, hemoglobin ≥ 90 g/l. * total bilirubin ≤ 1.5×uln, alt and ast ≤ 2.5×uln (or ≤ 5.0×uln for patients with liver metastases). * serum creatinine ≤ 1.5×uln, or creatinine clearance ≥50 ml/min. * international normalized ratio (inr) prothrombin time (pt) ≤1.5×uln, activated partial thromboplastin time (aptt) ≤1.5×uln. * blood pregnancy test results were negative for female patients with fertility potential. patients with fertility potential must agree to use a reliable method of contraception with their sexual partners during the study period and at least 6 months after the last administration. exclusion criteria: * other malignancies within 5 years prior to screening (other than cured stage ib or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer). * has a persistent or active infection that requires intravenous treatment. * history of severe cardiovascular and cerebrovascular disease. * patients with autoimmune diseases requiring drug control or at risk of recurrence of autoimmune diseases. * received any radiotherapy (other than palliative radiotherapy for bone metastases), chemotherapy, targeted therapy, immunotherapy, cell therapy, or other investigational anticancer agents within 4 weeks prior to first dose of ba1202, unless chemotherapy or targeted therapy is less than 4 weeks after first dose but has eluted ≥5 half-lives. * have received any previous cea targeting therapy, including but not limited to monoclonal antibodies, bisspecific antibodies, antibody-coupled drugs (adcs), chimeric antigen receptor t cells (car-t), etc. * a history of allergy to ba1202 or any component of obinutuzumab, or to other monoclonal antibodies. * women are planning to become pregnant or are pregnant or breastfeeding. * other conditions considered unsuitable for enrollment by the investigator.